Flebogamma® 5 % DIF Intravenous Immunoglobulin for Replacement Therapy in Children with Primary Immunodeficiency Diseases

Mark Ballow, Paul J. Pinciaro, Timothy Craig, Gary Kleiner, James Moy, Hans D. Ochs, John Sleasman, William Smits

Research output: Contribution to journalArticlepeer-review

4 Scopus citations

Abstract

Purpose: The previous studies with Flebogamma® 5 % DIF intravenous immunoglobulin (IVIG) contained insufficient numbers of pediatric subjects to fully warrant a pediatric indication by the FDA. The objective of this study was to evaluate the efficacy, safety, and pharmacokinetics of Flebogamma® 5 % DIF for replacement therapy in children (age 2–16) with primary immunodeficiency diseases (PIDD). Methods: IVIG was administered at eight clinical sites to 24 subjects with well-defined PIDD at a dose of 300–800 mg/kg every 21–28 days for 12 months. The pharmacokinetics endpoint in this study was the dose-adjusted increment of the serum IgG trough levels. Results: The calculated serious bacterial infection rate was 0.05/subject/year. The incidence of adverse events considered potentially related to IVIG during or within 72 h after completing an infusion was within the FDA guidance threshold of <40 % at each time point. Dose-adjusted incremental IgG levels remained approximately equal to or slightly greater than pre-study IgG levels (between 800 and 1000 mg/dL throughout) when the subjects were treated with IVIG therapy other than Flebogamma® DIF 5 % indicating no evidence of a different pharmacokinetic profile in this pediatric population if compared to those profiles in previous Flebogamma studies in predominately adult populations. Conclusions: Flebogamma® 5 % DIF is efficacious and safe, has adequate pharmacokinetic properties, is well-tolerated, and maintains the profile of Flebogamma® 5 % for the treatment of children with primary humoral immunodeficiency diseases.

Original languageEnglish (US)
Pages (from-to)583-589
Number of pages7
JournalJournal of Clinical Immunology
Volume36
Issue number6
DOIs
StatePublished - Aug 1 2016

All Science Journal Classification (ASJC) codes

  • Immunology and Allergy
  • Immunology

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